This study is to allow continued access to QTI571 for patients who received QTI571 for pulmonary arterial hypertension in one of the long-term extension studies (A2301E1, A2102E1 and E2203) and have been judged by the investigator to benefit from continued QTI571 treatment.

• Register: EUCTR
• Last refreshed on: 9 December 2013
• Main ID: EUCTR2013-001100-10-ES
• Date of registration: 12/11/2013
• Prospective Registration: Yes
• Primary sponsor: Novartis Farmacéutica, S.A.
• Public title: This study is to allow continued access to QTI571 for patients who received QTI571 for pulmonary arterial hypertension in one of the long-term extension studies (A2301E1, A2102E1 and E2203) and have been judged by the investigator to benefit from continued QTI571 treatment.
• Scientific title: An open-label, multi-center protocol to provide QTI571 to PAH patients who participated in one of the extension studies and are judged by the investigator to benefit from continued QTI571 treatment
• Date of first enrolment: 12/11/2013
• Target sample size: 81
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001100-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1

Countries of recruitment

Australia, Spain, Switzerland, United States

Contacts

• Name: Departamento Médico (ICRO)
• Affiliation: Novartis Farmacéutica, S.A.

• Name: Departamento Médico (ICRO)
• Affiliation: Novartis Farmacéutica, S.A.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patient is receiving QTI571 for the treatment of PAH and is currently enrolled in a longterm extension study (CSTI571E2203, CQTI571A2301E1, and CQTI571A2102E1).
2. Patient is currently benefitting from the treatment with QTI571 in the opinion of the investigator.
3. Written informed consent must be obtained prior to enrolling into the QTI571A2314
study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 67
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion criteria:
1. Patient has been permanently discontinued from QTI571 study treatment in the parent extension study.
2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
3. Concomitant use of oral vitamin K antagonist medication.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Pulmonary Arterial Hypertension
MedDRA version: 16.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Trade Name: GLIVEC 100 mg comprimidos recubiertos con película
Product Name: Imatinib mesilate
Product Code: QTI571
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IMATINIB MESILATE
CAS Number: 220127-57-1
Current Sponsor code: QTI571
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Primary end point(s): Not applicable

Timepoint(s) of evaluation of this end point: Not applicable

Main Objective: To provide continued treatment to PAH patients who are benefitting from treatment with QTI571

Secondary Objective: To collect long term data on serious adverse events.

Secondary Outcome(s)

Secondary end point(s): Not applicable

Timepoint(s) of evaluation of this end point: Not applicable

Secondary ID(s)

CQTI571A2314

Source(s) of Monetary Support

Novartis Pharma AG